Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Recall Z-0077-2013 · Posted 2012-10-18
Advertisement
Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2012-09-19
Date Terminated2014-01-21
Product Quantity275 units
Reason for Recall
Incidents regarding fractures of the front joint of the spring arm have been reported.
Firm Action
Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement